Long-term Beneficial Metabolic Effects of Adrenalectomy in Subclinical Cushing's Syndrome of Adrenal Incidentaloma

• Sponsor: Samsung Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT01382420
• Collaborator: Asan Medical Center (Other), Severance Hospital (Other), Konkuk University Medical Center (Other)
• Enrollment: 234
• Location: 1
• Arms: 2
• Duration (Months): 156
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

Objective:

To determine the metabolic effects of the adrenalectomy in subclinical Cushing's syndrome of adrenal incidentaloma.

Methods:

234 subclinical cushing syndrome and adrenal incidentaloma will be randomly assigned into two groups(e.g adrenalectomy group and conservative treatment group).

Condition or Disease	Intervention/Treatment	Phase
Cushing Syndrome	Procedure: surgery	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 234 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Long-term Effects of Adrenalectomy on Metabolic Syndrome, Glucose Metabolism, Lipid Metabolism, and Bone Metabolism in Subclinical Cushing's Syndrome of Adrenal Incidentaloma
• Study Start Date: May 1, 2011
• Anticipated Primary Completion Date: May 1, 2020
• Anticipated Study Completion Date: May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Adrenalectomy group patients who undergo adrenalectomy	Procedure: surgery; adrenalectomy
No Intervention: Control group patients who receive conservative treatment

Outcome Measures

Primary Outcome Measures

1. Change of lipid profile between two groups [4 Year]

   lipid profile with LDL,apo B

Secondary Outcome Measures

1. Incidence of obesity between two groups [4Year]

   measurement of body weight, height

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• patients with both unilateral adrenal incidentaloma and hypercortisolism

• definition of hypercortisolism

• overnight dexamethasone suppression test, serum cortisol>1.8ug/dL

• 24hr urine cortisol > upper reference limit

Exclusion Criteria:

• patients who took medication influencing cortisol secretion

• patients with definite clinical feature of cushing syndrome

• moon face

• abdominal striae

• skin or proximal muscle atrophy

• metabolic syndrome, hyperthyroidism, hyperparathyroidism, chronic renal failure, rheumatic disease, hematologic disease

• patients who took following medication

• insulin

• oral hypoglycemic agent

• thyroid hormone

• anti-hyperlipidemic drug

• sex hormone

• patients who taking steroid hormone or who took steroid hormone more than 2 weeks within 1 year

• psychiatric disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

• Samsung Medical Center
• Asan Medical Center
• Severance Hospital
• Konkuk University Medical Center

Investigators

• Study Director: Jae Hyeon Kim, Samsung Medical Center
• Study Chair: Jung-Min Koh, M.D, Ph.D
• Principal Investigator: Kee-Ho Song, M.D, Ph.D.
• Principal Investigator: Yumie Rhee, M.D, Ph.D.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jae Hyeon Kim, Associate Professor, Samsung Medical Center
• ClinicalTrials.gov Identifier: NCT01382420
• Other Study ID Numbers: 2011-03-034
• First Posted: Jun 27, 2011
• Last Update Posted: Apr 4, 2019
• Last Verified: Apr 1, 2019

• Keywords provided by Jae Hyeon Kim, Associate Professor, Samsung Medical Center: subclinical cushing syndrome; hypercortisolism; adrenal incidentaloma; adrenalectomy
• Additional relevant MeSH terms: Adrenocortical Adenoma; Cushing Syndrome; Syndrome

Study Results

No Results Posted as of Apr 4, 2019